MDSS Consulting GmbH

MDSS Consulting GmbH offers expert regulatory consulting for medical devices and IVDs, specializing in EUDAMED onboarding and compliance. They provide comprehensive support for registration and ongoing management.

MDSS Consulting GmbH is a specialized consultancy focused on regulatory affairs for medical devices and In Vitro Diagnostic (IVD) products. They offer extensive expertise in navigating complex regulatory landscapes, with a particular emphasis on EUDAMED compliance and onboarding. Their services include guidance on EUDAMED registration for various roles, product registration, and managing updates within the database. They assist clients in understanding the requirements for SRN numbers, actor registration, and timely reporting of product information. MDSS Consulting GmbH provides tailored support, from initial consultations to full outsourcing of EUDAMED-related tasks. They aim to simplify the often daunting process of regulatory compliance, ensuring clients can bring their products to market efficiently and safely. Their team is dedicated to providing clear, actionable advice and practical solutions for manufacturers and authorized representatives.

Key Highlights

  • MDSS Consulting GmbH specializes in EUDAMED onboarding and compliance for medical devices and IVDs. Source
    “MDSS Consulting GmbH offers expert regulatory consulting for medical devices and IVDs, specializing in EUDAMED onboarding and compliance.”
  • They provide support for obtaining EUDAMED registration numbers (SRN) for various roles. Source
    “benötigen für jede Rolle eine eigene EUDAMED Registriernummer (SRN) im Akteur-Modul”
  • The company offers interactive support via MS Teams/Zoom for EUDAMED-related tasks. Source
    “Interaktive Unterstützung via MS Teams/Zoom bei”
  • MDSS Consulting GmbH facilitates partial or full outsourcing of EUDAMED registration tasks. Source
    “Partielle/vollständige Auslagerung an unser Team für”
  • They offer a free initial consultation for regulatory needs. Source
    “Request a free initial consultation*.”

Certifications & Trust Signals

  • MDSS Consulting GmbH is based in Hannover, Germany. Source
    “Schiffgraben 4130175 HannoverGermany”

Buyer Snapshot

Best for
  • Companies needing EUDAMED registration support
  • Manufacturers and Authorized Representatives
  • IVD and Medical Device companies
How engagement typically works
  • Consulting and advisory services
  • Project-based support
  • Outsourcing of regulatory tasks
Typical deliverables
  • EUDAMED SRN acquisition support
  • Product registration assistance
  • Regulatory strategy development
  • Quality management system guidance
Good to know
  • Best when requiring specialized EUDAMED expertise
  • Best when seeking comprehensive regulatory support for medical devices and IVDs

Pricing

Model: Custom pricing
HQ: Hannover, Germany
Languages: English, German
Timezones: UTC+1
Status: listed

Services & Capabilities

EUDAMED Onboarding & Data Registration Support (Mandatory Modules)

Modules Supported: Actor/SRN
Submission Approach: Portal
Managed Service Available: Yes

Additional eudamed_onboarding_support Details

Modules Supported
Actor/SRN, UDI/Devices, Basic UDI/DI
Submission Approach
Portal operations, direct support
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